Dataset Information

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial.

ABSTRACT:

Background

Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality.

SUBMITTER: Israel E

PROVIDER: S-EPMC8130188 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial.

Israel Elliot E Cardet Juan Carlos JC Carroll Jennifer K JK Fuhlbrigge Anne L AL Pace Wilson D WD Maher Nancy E NE She Lilin L Rockhold Frank W FW Fagan Maureen M Forth Victoria E VE Hernandez Paulina Arias PA Manning Brian K BK Rodriguez-Louis Jacqueline J Shields Joel B JB Coyne-Beasley Tamera T Kaplan Barbara M BM Rand Cynthia S CS Morales-Cosme Wilfredo W Wechsler Michael E ME Wisnivesky Juan P JP White Mary M Yawn Barbara P BP McKee M Diane MD Busse Paula J PJ Kaelber David C DC Nazario Sylvette S Hernandez Michelle L ML Apter Andrea J AJ Chang Ku-Lang KL Pinto-Plata Victor V Stranges Paul M PM Hurley Laura P LP Trevor Jennifer J Casale Thomas B TB Chupp Geoffrey G Riley Isaretta L IL Shenoy Kartik K Pasarica Magdalena M Calderon-Candelario Rafael A RA Tapp Hazel H Baydur Ahmet A

Contemporary clinical trials 20201211

<h4>Background</h4>Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson ...[more]

PMID: 33316456

Similar Datasets

Project description:BackgroundBlack and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations.MethodsIn this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 μg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed.ResultsOf 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups.ConclusionsAmong Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

Project description:BackgroundInhaled corticosteroid (ICS) adherence rates are suboptimal among adult black/African Americans. Comprehensive studies characterizing the effectiveness and the methodological approaches to the development of interventions to improve ICS adherence in adult black/African Americans have not been performed.ObjectivesConduct a systematic review of patient/family-level interventions to improve ICS adherence in adult black/African Americans.MethodsWe searched MEDLINE, EMBASE, Web of Science, and CINAHL from inception to August 2017 for English-language US studies enrolling at least 30% black/African Americans comparing patient/family-level ICS adherence interventions with any comparator. Two investigators independently selected, extracted data from, and rated risk of bias. We collected information on intervention characteristics and outcomes, and assessed whether studies were informed by behavior theory, stakeholder engagement, or both.ResultsAmong 1661 abstracts identified, we reviewed 230 full-text articles and identified 4 randomized controlled trials (RCTs) and 1 quasi-experimental (pre-post design) study meeting criteria. Study participants (N range, 17-333) varied in mean age (22-47 years), proportion black/African Americans studied (71%-93%), and sex (69%-82% females). RCTs evaluated problem-solving classes, self-efficacy training, technology-based motivational interviewing program, and the use of patient advocates. The RCT testing self-efficacy training was the only intervention informed by both behavior theory and stakeholder engagement. All 4 RCTs compared interventions with active control and rated as medium risk of bias. No RCTs found a statistically significant improvement in adherence.ConclusionsFew studies assessing asthma adherence interventions focused on adult black/African-American populations. No RCTs demonstrated improved ICS adherence in participants. Future studies that are informed by behavior change theory and stakeholder engagement are needed.

Project description:BackgroundSerious psychological distress (SPD) is common and more prevalent in women, older adults, and individuals with a low-income. Prior studies have highlighted the role of low neighborhood social cohesion (nSC) in potentially contributing to SPD; however, few have investigated this association in a large, nationally representative sample of the United States. Therefore, our objective was to investigate the overall and racial/ethnic-, sex/gender-, self-rated health status-, age-, and household income-specific relationships between nSC and SPD.MethodsWe used data from survey years 2013 to 2018 of the National Health Interview Survey to investigate nSC and SPD among Asian, Non-Hispanic (NH)-Black, Hispanic/Latinx, and NH-White men as well as women in the United States (N = 168,573) and to determine modification by race/ethnicity, sex/gender, self-rated health status, age, and annual household income. nSC was measured by asking participants four questions related to the trustworthiness and dependability of their neighbors. nSC scores were trichotomized into low (< 12), medium (12-14), and high (15-16). SPD was measured using the Kessler 6 psychological distress scale with scores ≥ 13 indicating SPD. After adjusting for sociodemographic, health behavior, and clinical confounders, we used Poisson regression with robust variance to estimate prevalence ratios (PRs) and 95% confidence intervals (CIs).ResultsAmong 168,573 participants, most were Non-Hispanic (NH)-White (69%), and mean age was 47 ± 0.01 years. After adjustment, low vs. high nSC was associated with a 75% higher prevalence of SPD overall (PR = 1.75 [1.59-1.92]), 4 times the prevalence of SPD among Asian men (PR = 4.06 [1.57-10.50]), 2 times the prevalence of SPD among participants in at least good health (PR = 2.02 [95% CI: 1.74-2.35]), 92% higher prevalence of SPD among participants ≥ 50 years old (PR = 1.92 [1.70-2.18]), and approximately 3 times the prevalence of SPD among Hispanic/Latinx participants with household incomes ≥ $75,000 (PR = 2.97 [1.45-6.08]).ConclusionsLow nSC was associated with higher SPD in the overall population and the magnitude of the association was higher in Asian men, participants who reported good health, older participants, and Hispanic/Latinx adults with higher household incomes. Future research should continue to examine how neighborhood contexts can affect health across various sociodemographic groups, especially among groups with multiple marginalized social identities.

Dataset Information

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial.

Background

Publications

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets